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510(k) K895571

N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT by Tudor Laboratories, Inc. — Product Code LAN

K895571 is an FDA 510(k) premarket notification submitted by Tudor Laboratories, Inc. for the device "N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT". The FDA issued a decision of Substantially Equivalent on October 25, 1989. The device falls under product code LAN (Enzyme Immunoassay, N-Acetylprocainamide), a Class II device regulated under 21 CFR 862.3320. Tudor Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1989
Date Received
September 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, N-Acetylprocainamide
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Tudor Laboratories, Inc.

  • K921904 — THYROXINE (FPIA) KIT (June 24, 1992)
  • K921903 — THYROXINE CALIBRATOR KIT (May 26, 1992)
  • K913240 — DIGITOXIN (FPIA) KIT (September 6, 1991)
  • K895572 — N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT (October 30, 1989)
  • K895567 — PRIMIDONE (FPIA) KIT (October 20, 1989)
  • K895569 — VALPROIC ACID (FPIA) KIT (October 3, 1989)
  • K895570 — VALPROIC ACID (FPIA) CALIBRATOR KIT (September 28, 1989)
  • K895568 — PRIMIDONE (FPIA) CALIBRATOR KIT (September 28, 1989)

Other clearances for product code LAN

  • K060738 — TDM N-ACETYLPROCAINAMIDE (August 16, 2006)
  • K032564 — DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 (October 31, 2003)
  • K011620 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 (June 18, 2001)
  • K983812 — NAPA EIA ASSAY (November 16, 1998)
  • K971713 — N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (June 11, 1997)
  • K955422 — AXSYM N-ACETYLPROCAINAMIDE (April 24, 1996)
  • K934705 — OPUS NAPA (November 22, 1993)
  • K922915 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT (August 24, 1992)
  • K873349 — EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 (September 22, 1987)
  • K871680 — MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR (June 8, 1987)

FDA data resources